the anti-inflammatory and metabolic effects of rosiglitazone in subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: to assess whether the anti-inflammatory effects of rosiglitazone result in improvements in rheumatoid arthritis symptoms in patients for whom their existing disease modifying anti-rheumatic drug (dmard) treatment does not give adequate relief.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis insufficiently controlled by existing disease-modifying anti-rheumatic drugs * subjects will have at least 6 swollen joints plus 2 of the following: 6 tender joints (of 28 joints); early morning stiffness lasting more than 30 minutes; esr greater or equal to 28mm/h * must be receiving a stable dose of disease-modifying anti-rheumatic therapy for at least 2 months prior to participating in the study. exclusion criteria: * women who are lactating, pregnant, or planning to become pregnant during the course of the study including 30 days following conclusion of study medication * systolic blood pressure (sbp) \>165 mmhg or diastolic blood pressure (dbp) \>95 mmhg while receiving optimal antihypertensive therapy * any clinically significant abnormality identified on the screening physical exam, laboratory tests, or ecg, which in the judgement of the investigator makes the subject unsuitable for inclusion in the study * a history of alcohol abuse within the past 3 years or consumes \>3 units per day for males and \>2 units per day for females or has a history of cirrhosis or stigmata of chronic liver disease * a history of liver disease or has alanine aminotransferase (alt) or aspartate aminotransferase (ast) levels \>2.5 times upper limit of normal and total bilirubin levels greater than 1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin or gilbert's syndrome) at screening * using glucocorticoid at doses \>10 mg/day currently or within the last 3 months or may be expected to do so during the course of the study * the subject's dose of nsaids, cox-2 inhibitors or glucocorticoids has changed at any time during the past 2 weeks prior to screening or may be expected to change during the course of the study * the subject's dose or treatment with a statin has changed at any time during the past 3 months prior to screening or may be expected to change during the course of the study * a history of renal disease or has serum creatinine = 132mol/l for males and =130mol for females * has diabetes mellitus that requires medication or hyperglycaemia with a hba1c of \>7% * history of new cardiovascular event within the last 6 months (i.e., intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome \[non q-wave myocardial infarction, q-wave myocardial infarction, unstable angina) or significant arrhythmia; or major intervention (e.g., cardiac surgery or angiography plus stenting) scheduled * concurrent or past medical history of congestive heart failure or pulmonary oedema * a presence of severe peripheral oedema or a medically serious fluid-related event * has significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or immunological conditions that, in the opinion of the investigator and/or gsk medical monitor, places the subject at an unacceptable risk as a participant in this trial * a history of malignancy in the last 5 years, except for surgically cured basal cell carcinoma (\>2 years prior to first dosing) * a history of hiv, or chronic hepatitis b or positive c serology * a history of drug abuse * has participated in a clinical trial within the 3 months before the start of the study for non-biological therapy; or within 6 months of a biological therapy * on a biological therapy or has received biological therapy within 6 months prior to screening * has donated blood in excess of 500 ml within 56 days prior to dosing * the subject is at risk of non-compliance in following directions or adhering to study restrictions * a history of drug or other allergy, which, in the opinion of the physician responsible, contraindicates their participation * has anaemia defined by haemoglobin concentration \<11 g/dl for males or \<10 g/dl for females

Keywords: anti-inflammatory treatment rheumatoid arthritis